Doubling Outcomes by Lung Cancer Early Diagnosis: An Observational, Study to Collect Real-world Evidence (RWE) on the Management of Pulmonary Nodules Across Latin-America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Time of nodule identification up to diagnosis and treatment
研究概览
简要总结
Early diagnosis of LC in the asymptomatic stage through intentional screening programs and/or incidental pulmonary nodule identification and follow-up are known to improve outcomes significantly. There are large gaps in the screening and early detection of LC, especially in LMIC - driven by multifactorial aspects, including a variety of socioeconomic and infrastructural factors, mainly due to limitations in the required network of specialized human resources and technical capacity. Identifying LC at an early stage allows for treatment that is more likely to be curative, thereby improving survival.
The present study aims to characterize the lung nodule journey in different hospitals/clinics across Latin America, describing the use of health resources, time to diagnosis, stage at diagnosis, and time to treatment depending on the source of nodule identification in two different cohorts (retrospective and prospective).
详细描述
This non-interventional observational study will capture data (retrospective and prospective cohorts) from around 20 to 25 hospitals/clinics to report lung nodules (patients' journey) in Latin America.
Objectives and Hypotheses:
Primary objective
• To describe the lung nodule patient journey from the time of nodule identification through its final diagnosis, staging, and treatment decision.
Note: Lung nodules identified from different settings would be nodules identified incidentally and in lung cancer screening programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 35 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥ 35 years of age)
- •a) Prospective cohort: All eligible subjects with solid or subsolid (part solid, pure ground glass) lung nodule identified in imaging exams in routine clinical practice, prior to 30 days of informed consent given [please refer to: Fleischner Society 2017 guidelines for nodules size and definition (≥ 6 mm and < 3 cm)) for subject inclusion]. Subjects identified from different sources (Nodules identified incidentally and in lung cancer screening programs) will be considered OR b) Retrospective cohort: All eligible subjects with solid or subsolid (part solid, pure ground glass) lung nodule identified in the past; more preciously from March 2019 to the study initiation date. [Please refer to: Fleischner Society 2017 guidelines for nodules size and definition (≥ 6 mm and < 3 cm) for subject inclusion].
- •Written informed consent to have medical data collected and stored for the prospective cohort and as guided by the local regulations for the retrospective cohort..
排除标准
- •Subjects unable to undergo any lung diagnostic procedure.
- •Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence of that malignancy
- •Subjects with calcified lung nodules with an established diagnosis
结局指标
主要结局
Time of nodule identification up to diagnosis and treatment
时间窗: 24 months
Description of the lung nodule patient journey from the time of nodule identification through its final diagnosis, staging, and treatment decision.
次要结局
未报告次要终点